Job Description

:Responsible for developing solutions to challenging issues associated with the design, development, and sustenance engineering for our new and existing Disposables for the Acute Therapies product portfolio. Independently drive/contribute to the Projects/Initiatives involving Engineering change management, solutions for Product quality issues, root cause analysis, NCR handling, CAPAs, verification & validation, design transfer, Value improvement programs and Regulatory compliance activities. Contribute to the development of new functions/features to be integrated into the existing products/new products.Essential duties and responsibilities:

• Lead/Support the R&D activities of Disposables products.
• Lead/support the overall labeling activities for Acute Disposables product families.

Manages all technical complexities of the work, and effectively communicates with all project team members and stakeholders. This includes reporting pertinent information at key milestones.

• Defines the required tasks, test plans, deliverables, and technical direction. Constructs detailed, accurate project schedules interfacing with product development, quality, regulatory, manufacturing, and other cross functional teams.
• Develops solutions and approaches to complex problems through application and adaptation of state-of-the-art techniques and sound analysis-based engineering by applying principles of mechanics, thermodynamics, hydraulics, heat transfer and materials where required.
• Able to clearly present moderately complex concepts and tailor communication to audiences, including senior management.
• Organizes and presents technical project management overviews without assistance. Oral and written communication is well planned, organized and has a clear logical flow.
• Ensures successful integration of disposables design elements into the overall system. Resolves competing constraints between interrelated functions (R&D, purchasing, manufacturing, regulatory, marketing, etc.) required to complete the engineering and design tasks.
• Able to design Plastic components with expertise in manufacturing of plastic components.
• Creates and maintains design documentation that includes requirements, specifications, verification reports, Bill of Materials, detailed engineering drawings, study reports and all documents that contribute to DHF of the product family.
• Leads troubleshooting and problem-solving efforts of the products associated with field performance and manufacturing. Ensures Systems that are optimized for production, reliability, regulatory compliance, and cost.
• Performs in-depth mechanical engineering analysis and calculations.
• Defines protocols and conduct the necessary testing required to validate the safety and effectiveness of the design(s). Develop test plans, test protocols, and test reports for product integration testing, also develops the infra required for the testing.
• Responsible for validation of test methods and developing new test methods.
• Adheres to client\'s Quality Management system and support audits and external inspections as applicable.

Education and Experience

• Graduate or Postgraduate in Mechanical Engineering/Bio Medical Engineering/Polymer Engineering or Equivalent.
• Minimum 5 years of R&D experience in New product development/Sustenance.
• Prior experience of technical leadership in Sustenance/New product development in Medical device domain is a plus.
• A proven track record of management/leadership effectiveness in a fast-paced environment.
• Proven ability to create results within budget, timeline, and product/project deliverables.

Rangam Infotech